EVALUATION OF OVARIAN PAIN AND QUALITY OF LIFE

卵巢疼痛和生活质量的评估

• 批准号: 6237131
• 负责人: Russell K Portenoy
• 金额: $ 15.34万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-01 至 1998-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6237131
• 关键词: analgesics; anticholinergic agent; behavioral /social science research tag; cancer complication; cancer pain; central nervous system stimulants; clinical trials; fatigue; female; human subject; human therapy evaluation; interview; longitudinal human study; methylphenidate; neoplasm /cancer chemotherapy; neoplasm /cancer palliative treatment; neoplasm /cancer remission /regression; ovary neoplasms; oxazolidone; patient care management; psychological stressor; quality of life; quaternary ammonium compound; scopolamine; syndrome; women's health

During our previous study of patients with ovarian cancer, we observed a high prevalence of pain, fatigue, and psychological distress among those with persistent disease and noted the existence of a stereotypical pain syndrome that heralded disease onset in a majority of patients. In this application, we propose studies that evaluate novel management strategies for each of these major symptoms and attempt to determine the importance of this newly described pain syndrome. The abdominal pain associated with malignant bowel obstruction is a challenging problem that may not respond satisfactorily to opioid therapy. Despite a lack of data from controlled studies, anticholinergic drugs are now used empirically as adjuvant analgesics in this setting. Study 1 of this proposal is a placebo-controlled, parallel-group, repeated-dose comparison of scopolamine and glycopyrrolate, two commercially available anticholinergic drugs that may differ in side effects due to variable penetrance of the blood-brain barrier. Cancer- related fatigue also never been studied in controlled fashion, despite its very high prevalence. We propose two controlled trials that will be the first to evaluate the safety and efficacy of psychostimulated drugs for this condition. Study 2 is a placebo-controlled, repeated-dose, parallel-group efficacy trial of the psychostimulant methylphenidate; and Study 3 is a placebo-controlled, repeated-dose, parallel-group comparison of methylphenidate and the novel psychostimulant pemoline. The latter drug may be particularly useful in the ovarian cancer population due to the availability of a chewable formulation and a side-effect profile that may be better than other stimulants. Given the high prevalence and adverse impact of pain and psychological distress in the ovarian cancer population, new approaches are needed for the long-term management of these problems. In the Study 4, we proposed a randomized trial that will evaluate the utility of a prospective telephone screening program, which has been designed to identify and provide early intervention for those patients with active ovarian cancer who experience unrelieved pain or heightened psychological distress. Finally, we propose to replicate and further define our previous findings that a stereotypical pain syndrome may herald the onset of disease in those who achieve remission following primary therapy. Study 5 is a prospective longitudinal survey of this subpopulation, which will additionally provide information about the potential of pain monitoring as a means of improving early diagnosis. The information acquired through these studies will have important implications for the supportive care of patients with ovarian cancer.

在我们先前对卵巢癌患者的研究中，我们观察到 疼痛，疲劳和心理困扰的高度流行 那些持续性疾病的人，并指出存在刻板印象 疼痛综合症预示了大多数患者的疾病发作。 在 我们提出了这项应用程序，以评估新型管理 这些主要症状的策略，并试图确定 这种新描述的疼痛综合征的重要性。 与恶性肠梗阻有关的腹痛是 具有挑战性的问题可能对阿片类药物不满意 治疗。 尽管缺乏对照研究的数据，但抗胆碱能 在这种情况下，药物现在被经验用作辅助镇痛药。 该提案的研究1是安慰剂对照的平行组， 重复的剂量比较西代牙质和糖吡啶甲酸，两个 可能在侧面有所不同的市售抗胆碱能药物 由于血脑屏障的渗透性变化而产生的影响。 癌症- 尽管 它的患病率很高。 我们提出了两个对照试验 第一个评估精神刺激药物的安全性和有效性 对于这种情况。 研究2是安慰剂对照的，重复的剂量， 精神刺激甲基苯甲酸酯的平行组功效试验；和 研究3是安慰剂对照，重复剂量的平行组比较 哌醋甲酯和新型的精神刺激性佩莫林。 后者 由于 可用的咀嚼公式和副作用轮廓的可用性 可能比其他兴奋剂更好。 考虑到高流行率和 疼痛和心理困扰对卵巢癌的不利影响 人口，需要新的方法来长期管理 这些问题。 在研究4中，我们提出了一项随机试验，将 评估预期电话筛查计划的实用性，该计划 旨在识别并为那些人提供早期干预 活跃的卵巢癌患者患有不舒服的疼痛或 心理困扰增加。 最后，我们建议复制和 进一步定义了我们以前的发现，即刻板印象疼痛综合征 愿预示着那些疾病的发作 一级疗法。 研究5是对此的前瞻性纵向调查 亚种群，该群还将提供有关 疼痛监测作为改善早期诊断的手段的潜力。 通过这些研究获得的信息将具有重要的 对卵巢癌患者的支持护理的影响。